Drugs FDA Approval Insulin Licensing 
Drug Discovery World
FEBRUARY 23, 2024
In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space. The post This week in drug discovery (19-23 February) appeared first on Drug Discovery World (DDW).
XTalks
OCTOBER 22, 2021
The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition.
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pharmaphorum
NOVEMBER 21, 2022
The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D. It also has an option on global marketing rights to the drug.
XTalks
JUNE 5, 2023
Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.
The Pharma Data
AUGUST 17, 2021
approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.
Roots Analysis
FEBRUARY 22, 2022
Further, in order to improve the quality of life in these patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies, in an efficient and relatively simple manner. Autoinjector As Emerging Drug Delivery Device. Rising Need of Autoinjectors – Roots Analysis.
FDA Law Blog
FEBRUARY 7, 2022
Further, though any relevant discussion is redacted, the Untitled Letter suggests that FDA had previously provided comments to Lilly about its Trulicity promotion more generally. These issues are not new—although the fact that this is an Instagram post with video raises a new context for considering them. So what’s the takeaway here?
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